Allow zero value and enhance auto-calculation logic of Gestation Period at Exposure

Summary

Allow zero value and enhance auto-calculation logic for the Gestation Period at Exposure field in the Products tab (Enhancement 37812168)

Description

Argus Safety is enhanced to enter and save zero (0) as a valid value in the Case Form > Products > Gestation Period at Exposure field.

Additionally, the auto-calculation logic is refined as follows:

• The gestation period is automatically calculated as the difference between the Date of First Dose for the product and the LMP Date, when available.
• This auto-calculation is performed only if the Due Date (from Pregnancy information) is greater than or equal to the First Dose date for the product.

Note:

• Both the First Dose and LMP Date fields must have complete dates for the calculation to proceed. If LMP Date and Due Date are available for both patient and parent, then the patient’s data is prioritized for auto-calculation.
• You can now manually enter or edit the Gestation Period at Exposure value. If a value is manually entered, the system will not overwrite this entry with the auto-calculated data upon saving.

The Gestation Period at Exposure value, including 0 with the unit Days/Weeks/Months/Trimester, is now correctly populated in the E2B(R2) and E2B(R3) files.

• E2B(R2) for ICH, EMA, FDA profiles
  • REACTIONGESTATIONPERIOD[B.4.k.10a]
  • REACTIONGESTATIONPERIODUNIT[B.4.k.10b]
• E2B(R3) for ICH, EMA, FDA, MFDS, NMPA and PMDA profiles
  • REACTIONGESTATIONPERIOD[G.k.6a]
  • REACTIONGESTATIONPERIODUNITR3[G.k.6b]
• During E2B(R3) and E2B(R2) files import, the UI fields for the Gestation Period at Exposure and Unit fields is populated when the value 0 and corresponding unit as present in the imported XML:E2B(R2) for ICH, EMA, FDA profiles.
  • REACTIONGESTATIONPERIOD[B.4.k.10a]
  • REACTIONGESTATIONPERIODUNIT[B.4.k.10b]
• E2B(R3) for EMA and PMDA profiles
  • REACTIONGESTATIONPERIOD[G.k.6a]
  • REACTIONGESTATIONPERIODUNITR3[G.k.6b]

For more information, refer to the E2B(R3) and E2B(R2) Export and Import mapping documents.